Tag Archives: BCMA

Gilead Files Tecartus’s sBLA in Adult R/R ALL; AUTO1 Receives PRIME Designation by the EMA; JNJ / Legend Complete Cilta-cel’s Rolling BLA in the US; BMS Files Abecma in Japan for R/R MM; Precision’s New CEO Transition Plan

Ahead of AACR, a series of cell therapy-related news items have been observed:

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

First BCMA CAR-T Approved in the US for Multiple Myeloma; Will Abecma’s 33-day TAT and High Price Prevent Wide-Spread Adoption?

On Friday, March 26, BMS and bluebird bio announced (press release) that the FDA approved Abecma (idecabtagene vicleucel) for the treatment of ≥5L r/r MM (i.e. after completing at least 4 lines of prior therapy). Below, Celltelligence provides thoughts on Abecma’s higher list price and longer TAT vs. approved CD19 CAR-Ts, while discussing Abecma’s potential messaging strategy.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Ide-cel Approved by FDA as Abecma in r/r MM After Four Lines of Previous Therapy

Late yesterday evening, BMS and bluebird bio announced US approval of ide-cel after completing at least 4 lines of prior therapy in r/r MM (BMS press release). The press release states that Abecma is a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Of note, Abecma will be manufactured at BMS’s facility in Summit, New Jersey, with a median TAT of 33 days. The Celltelligence team will be conducting a full thoughts-on label review in the coming days (link to Abecma PI here).

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Cilta-cel’s Japanese BLA Submission Anticipated for H2 2021; CARTITUDE-1 and CARTITUDE-2 Clinical Updates Expected in 2021; No Major Updates for Precision BioSciences; Legend and Precision Q4 2020 Earnings Call Summaries

On Thursday, March 18, Legend held their Q4 2020 earnings presentation (press release / presentation), highlighting the anticipated BLA submission of cilta-cel in Japan, while providing further details on cilta-cel’s rolling submission in the US. Furthermore, Precision BioSciences released their Q4 2020 results (press release), however no major clinical or regulatory updates were provided. Below, Celltelligence provides insights on how cilta-cel’s expansion within Asia could become an important revenue source for JNJ / Legend in the long term.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Thoughts on Autolus’s New Dual BCMA x CD19 CAR-T Ph1 Trial in Multiple Myeloma

On Friday, March 12, a new Autolus Ph1 trial named MCARTY was observed on CT.gov for a first-in-human study of a BCMA and BCMA x CD19 dual CAR-T in r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Autolus could differentiate themselves from competitors with BCMA CAR-T products closer to approval, while discussing engineering and dosing differences between BCMA x CD19 dual CAR-Ts from Autolus and Gracell.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Thoughts on Heidi Hagen’s Appointment as Interim Ziopharm CEO; Allogene Anticipates Two New Clinical Trials in 2021; Ziopharm and Allogene Q4 2020 Earnings Call Summaries

On Thursday, February 25, Ziopharm (press release / slides) and Allogene (press release) held their Q4 2020 earnings presentations. Ziopharm announced that Heidi Hagen will act as Interim CEO replacing Laurence Cooper, while Allogene presented several clinical and regulatory updates. Below, Celltelligence provides insights into Allogene’s pipeline strategy and their efforts to target the solid tumor setting in the mid- to long-term, while providing thoughts on the appointment of Heidi Hagen as Ziopharm’s Interim CEO.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Ide-cel Reverts to Standard Assessment; Liso-cel’s Potential Scenarios for Approval; CHMP February Agenda and Highlights

On Friday, February 26, CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, regulatory updates for BMS’s liso-cel (CD19) and ide-cel (BCMA) CAR-T products were observed, including ide-cel’s start of standard review following its loss of accelerated assessment (AA) in December 2020. No updates for cilta-cel were provided. Below, Celltelligence provides insights on possible EC approval dates for liso-cel and ide-cel.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

No Regulatory Updates for Liso-cel; Orva-cel Discontinued; BMS Q4 2020 Earnings Call Summary

On Thursday, February 4, BMS held their Q4 2020 results (press release / presentation). Management discussed liso-cel’s possible imminent approval and their strategy for rapid ATC onboarding. Of note, BMS’s humanized BCMA CAR-T orva-cel has been discontinued. Below, Celltelligence provides insights on BMS’s potential strategy for liso-cel and thoughts on orva-cel’s discontinuation.

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

JNJ / Legend Granted EU Accelerated Assessment for Cilta-cel; Can Cilta-cel’s MAA Submission Occur Before March 8, 2021?

On Monday, February 1, JNJ and Legend announced (press release) that the EMA granted cilta-cel (BCMA CAR-T) accelerated assessment for r/r MM. Management confirmed that they intend to file cilta-cel’s MAA during H1 2021. In case you missed it from January 25, Celltelligence revisits the likelihood of JNJ submitting an MAA by March 8, 2021 and cilta-cel’s potential regulatory timeline compared to ide-cel’s (BMS / bluebird).

About The Author

The Celltelligence Team

|
Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.